FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophy
TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 18, 2024 Category: Drugs & Pharmacology Source Type: news
Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 15, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Bristol Myers Squibb ’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
PRINCETON, N.J.--(BUSINESS WIRE) Mar 14, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news
Mirum Pharmaceuticals ’ Livmarli Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis
FOSTER CITY, Calif.--(BUSINESS WIRE) March 13, 2024 -- Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved Livmarli® (maralixibat) oral solution for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 13, 2024 Category: Drugs & Pharmacology Source Type: news
Praluent (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol
TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food& Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 11, 2024 Category: Drugs & Pharmacology Source Type: news
Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease
Bagsværd, Denmark, 8 March 2024– Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 8, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra
March 7, 2024 -- Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the United States (U.S.)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 7, 2024 Category: Drugs & Pharmacology Source Type: news
BeiGene Announces FDA Accelerated Approval of Brukinsa for the Treatment of Relapsed or Refractory Follicular Lymphoma
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.-- Mar 07, 2024 (BUSINESS WIRE)-- BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 7, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Approves Opdivo (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE) Mar 07, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 7, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Besponsa (inotuzumab ozogamicin) for Pediatric Patients with Acute Lymphoblastic Leukemia
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Efficacy was... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva.
The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia.
The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines
NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 4, 2024 Category: Drugs & Pharmacology Source Type: news